MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA 5000A; CATHETER, CORONARY, ATHERECTOMY

Model Number 45038

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that the procedure could not be completed.An angiojet console was selected for use.However, it was noted that the roller pump refused to work.Due to this issue, the procedure could not be completed.No patient complications were reported.

Manufacturer Narrative

B3: date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that the procedure could not be completed.An angiojet console was selected for use.However, it was noted that the roller pump refused to work.Due to this issue, the procedure could not be completed.No patient complications were reported.It was further reported that the device kept giving a roller pump error and would not load the catheter.The procedure was completed with a non-bsc device.

• Brand Name: ANGIOJET ULTRA 5000A
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19203615
• MDR Text Key: 341294064
• Report Number: 2124215-2024-25227
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45038
• Device Catalogue Number: 45038
• Device Lot Number: U6367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1